Ear coupler

ABSTRACT

A one-piece, transparent flexible ear coupler for use with hearing evaluation is disclosed. It includes an annular side wall and a bottom wall forming an acoustic chamber. A flexible adhesive-backed flange is disposed on the periphery of the ear coupler. The flange attaches to the subject&#39;s head, firmly holding the ear coupler in place over the ear. The annular side wall has a port for the placement of a transducer assembly, and also has ribs to help lock the transducer assembly in place. The transducer assembly can be placed in an up or down position, and can be switched between positions while the coupler is attached to the subject&#39;s head. The ear coupler advantageously conforms to the subject&#39;s head, thereby minimizing the likelihood that the ear coupler will become detached during testing. The coupler can be inexpensively manufactured, since its one-piece design allows the use of relatively low-cost processes such as injection molding and thermoforming.

RELATED APPLICATIONS

[0001] The present application is a continuation of U.S. Ser. No.09/941,132, filed Aug. 27, 2001.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to ear couplers or earphones thatcover the ear to create a desired acoustic environment.

[0004] 2. Background of the Invention

[0005] It is inherently difficult to determine hearing impairment ininfants, since they cannot participate in traditional hearing testswhich require subjects to indicate whether they can hear various sounds.However, if hearing impairment is not detected until the infant growsinto a toddler or child, then the potential for long-term disabilityincreases, since the child's language skills will have developed beforeremedial measures have been undertaken. The optimal time to screen forhearing impairment is immediately after birth, both because earlydetection allows for early treatment, and because parents often fail tobring their children in for later appointments.

[0006] Devices and methods have been developed to evaluate infanthearing by subjecting an infant to an aural stimulus, and then measuringthe electroencephalographic or otoacoustic response to that stimulus.These devices and methods depend on the creation of the proper acousticenvironment about the subject's ear, so that ambient noise does notinterfere with the hearing evaluation, and so that the stimulus has theappropriate duration, amplitude, and frequency content.

[0007] To create the desired acoustic environment, earphones or earcouplers have been used. Information relevant to previous ear couplerscan be found in U.S. Pat. Nos. 5,826,582, 4,930,520, and in U.S. patentapplication Ser. No. 09/395,799. Although many of these devices haveworked well, they can sometimes become detached from the subject's head,because of the variable and irregular surfaces surrounding the ear, andbecause infants tend to move during testing. Additionally, with previousear couplers, the assembly that houses the stimulus-producing transducertends to tug the ear coupler away from the ear. Existing ear couplersare also relatively expensive to manufacture, in part because theyrequire production or assembly of more than one part.

[0008] It is therefore desirable to construct an ear coupler that isbetter able to remain attached to the subject's head, and that is notsubject to being tugged off the head by forces acting on the transducerhousing. It is also desirable to design a one-piece ear coupler that canbe inexpensively manufactured by injection molding or other suitableprocesses.

BRIEF SUMMARY OF THE INVENTION

[0009] The present invention is a transparent one-piece ear coupler,with an internal chamber that creates a tuned acoustic environment aboutthe subject's ear, with a port to accommodate a transducer, and with aflange positioned around the periphery of the coupler to attach thecoupler to the subject's head.

[0010] Other features of the preferred embodiment of the presentinvention include a tab to facilitate removal of the ear coupler, and amark or target on the coupler to help ensure proper alignment over thesubject's ear. The coupler is generally D-shaped, and is designed so asto fit on either ear. Preferably, the coupler is made of transparentRimflex® thermoplastic elastomer, although other flexible, transparentmaterials could be used. The bottom wall of the coupler containswaffle-shaped or other surface features, which add rigidity and createthe desired acoustic characteristics of the chamber.

[0011] The exterior wall of the coupler is ribbed to provide means tosecurely lock in place the housing that contains the transducer. Theside of the flange in contact with the skin contains hydrogel or anotheradhesive substance to stick to the subject's head. The interior surfaceof the flange may also contain waffle-shaped or other surface featuresfor improved adhesion of the hydrogel to the Rimflex®, although no suchextrusions are provided in the preferred embodiment of this invention.The walls of the coupler are of sufficient thickness to resist crushing,and to provide the desired acoustic environment about the subject's ear.

[0012] The housing that contains the transducer, known as an acoustictransducer assembly (ATA), securely and positively fits into the portthat enters into the internal chamber. The ATA latches onto ribs on thesides of the coupler, and can be rotated up or down while in use, sothat the length of the ATA can placed either above or below the centerof the coupler.

[0013] Before being attached to the subject's head, the ear couplers areattached to release paper. Preferably, the adhesive that secures the earcouplers to the release paper (and to the subject's head) is a hydrogel,which can be selectively applied only to the flange of the ear couplerduring manufacture, thereby minimizing waste. There are holes in therelease paper, centered over the chamber of the ear coupler, to help theuser hold the coupler while the ATA is being inserted.

[0014] In operation, the ATA is inserted into the port, and the earcoupler is removed from the release paper and placed on the subject'sear. The adhesive on the flange sticks to the subject's head, andbecause of the unique features of the invention as disclosed herein, theear coupler will tend to stay affixed to the infant's head, even if heor she moves during testing. The tab helps remove the ear coupler fromthe release paper, and helps remove it from the subject's head when thetesting is complete.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]FIG. 1 is an elevated perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention.

[0016]FIG. 2 is an elevated perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention, fromthe opposite side as FIG. 1.

[0017]FIG. 3 is a bottom elevated perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention.

[0018]FIG. 4 is a top plan view of the ear coupler in accordance with apreferred embodiment of the present invention, with the ATA.

[0019]FIG. 5 is a side view of the ear coupler with the ATA inaccordance with a preferred embodiment of the present invention.

[0020]FIG. 6 is a side view, from a different perspective than FIG. 5,of the ear coupler with the ATA in accordance with a preferredembodiment of the present invention.

[0021]FIG. 7 is an elevated side perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention, withthe ATA.

[0022]FIG. 8 is an elevated side perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention, withthe ATA, from the opposite perspective of FIG. 7.

[0023]FIG. 9 is an elevated perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention, withthe ATA.

[0024]FIG. 10 is an elevated perspective view of the ear coupler inaccordance with a preferred embodiment of the present invention, withthe ATA, from the opposite perspective of FIG. 9.

[0025]FIG. 11 shows movement of the ATA between the up and downpositions.

[0026]FIG. 12 shows the ear coupler in accordance with a preferredembodiment of the present invention being worn by an infant, with theATA in both the up and down positions.

DETAILED DESCRIPTION

[0027] The present invention comprises a one-piece, transparent earcoupler body, 10, with an annular side wall, 20, a bottom wall, 30, aninternal chamber, 40, a peripheral flange, 50, a port, 60, an ATA, 70,and a tab, 80. Various aspects and features of the preferred embodimentof this invention are described below.

[0028] The ear coupler body, 10, is generally D-shaped, and sized to fitan infant's ear. It is made of a flexible, transparent, smooth,non-crumbly, nonporous material, preferably Rimflex®, which is availablefrom Bay State Polymer Distribution, Inc., P.O. Box 40055, Bay Village,Ohio 44140. Other suitable materials include Kraton, PVC, polyurethane,and Engage. By using a transparent material, the ear coupler can moreeasily and accurately be placed over the subject's ear. Opaque materialscan be used to create the desired acoustic environment, but they do notallow the clinician to visualize the placement of the coupler over thecenter of the subject's ear.

[0029] Preferably, the ear coupler is comprised of one-piece, which mayresult in lower manufacturing costs compared with multi-piece couplers.However, the coupler can be composed of more than one piece, so long asthe pieces or their connections are flexible enough so that ear couplercan accommodate the irregular and curved shape of a subject's head. Theear coupler can be made by injection molding, thermoforming, and otherprocesses. The ear coupler is not “handed,” meaning that it can fit oneither the right or left ear. The ear coupler is provided clean, and canbe sterilized as needed for certain applications. The ear coupler isdesigned to be disposable.

[0030] The annular side wall, 20, forms a ring around the internalportion of the ear coupler. Preferably, the annular side wall forms aD-shaped ring, although other shapes could be used. The D-shape helps toorient placement of the coupler, so that it is placed with the ATAproviding the stimulus from the front of the ear. The annular side wallcontains two or more ribs, 22, that are used to removably latch the ATAin place, as described below.

[0031] The annular side wall should be thick enough to provide crushresistance, and in the preferred embodiment is approximately ⅛th of aninch thick. Ribs, 22, can also be used to improve crush resistance, butin the preferred embodiment, the annular side wall provides sufficientstrength on its own. The annular side wall is of uniform thickness,except around the port, 60, where it is substantially thinner in orderto help create the interference fit as described below.

[0032] The bottom wall, 30, is attached to or integral with the annularside wall. Like the annular side wall, the bottom wall is thick enoughto resist crushing when the subject lies on his or her ear. In thepreferred embodiment, the bottom wall is approximately {fraction(1/16)}th of an inch thick.

[0033] To improve the acoustics of the ear coupler, the surface(exterior or interior) of the bottom wall contains a pattern of surfacefeatures, 32. Preferably, these surface features are a pattern ofcross-hatched protuberances that create a waffle-type surface. Thesesurface features add strength and rigidity to the bottom wall, andprevent it from vibrating in response to the stimulus. If the bottomwall were subject to vibration, then the ear coupler would createdifferent acoustic environments based on whether the bottom wall wasunder pressure or not. For instance, if the subject were lying on his orher back, then the bottom wall could vibrate, but if the subject werelying on his or her side, then the ear coupler could be pressed againstthe bed, thereby inhibiting vibration. By adding the surface features,the ear coupler is not subject to any such vibration regardless of thesubject's position, and thus the ear coupler creates the consistent andpredictable acoustic environment needed for accurate hearing screening.

[0034] The bottom wall also preferably includes a target indicating thecenter of the coupler, to help facilitate proper placement of thecoupler over the subject's ear. The bottom wall could also be imprintedwith text, such as the name or trademark of the company manufacturing orselling the ear coupler.

[0035] The chamber, 40, is formed by the annular side wall and thebottom wall, and is sufficiently large to accommodate the subject's ear.The chamber creates a tuned, isolated acoustic chamber, with preciseacoustic properties so that hearing screening can be conducted. Auralstimuli are transmitted into the chamber through the port.

[0036] The flange, 50, extends around the periphery of coupler,projecting out past the annular side wall. The flange may be centeredover the internal chamber, or can begin at the annular side wall. Theflange can be cut or slit to increase its ability to conform to thesubject's head, and indeed, multiple flanges could be used. In thepreferred embodiment, as reflected in the drawings, a single unitaryflange beginning at the annular side wall is used. The flange should beflexible, so that it can securely attach to the curved and irregularshape of a subject's head.

[0037] The flange is relatively planar or smoothly tapered, but may havebarriers at the inner and outer periphery to help contain the adhesive.In the preferred embodiment, these barriers take the form of slightridges that prevent overflow when the flange is coated with adhesiveduring manufacture.

[0038] The preferred adhesive is hydrogel, although other adhesivescould be used so long as they allow the coupler to be removably attachedto the subject's head. Previous ear couplers have used a laminate foradhesion, which resulted in wasted material, since the adhesive patternhad to be punched from a sheet of hydrogel material. Under the presentinvention, the hydrogel is selectively applied only to the flange, andthen placed on the release paper, resulting in minimal waste.

[0039] The flange, coated with adhesive, is the preferred structure toremovably attach the ear coupler to the subject's head. However, if aflange is not used, then the ear coupler could be attached to thesubject's head by any number of conventional means, such as tape, clips,a headband, or adhesive applied to the periphery of the coupler or to aflexible extension attached to the periphery.

[0040] The hydrogel may have a pattern of surface features, 52, on thesurface that contacts the infant's head. These surface features mayimprove adhesion of the flange to the Rimflex®, although they are notpresent in the preferred embodiment of this invention.

[0041] The flange extends from the annular side wall a sufficientdistance for proper adhesion. In a preferred embodiment of presentinvention, the flange extends approximately {fraction (1/4)} inch fromthe annular side wall.

[0042] The port, 60, is an opening in the annular side wall forplacement of the ATA, 70. Preferably, the port is sized to create aninterference fit with the ATA, so that there is some initial resistancewhen placing the ATA in the port, and then there is a click or snap whenthe ATA is pushed into place. For purposes of this patent, “interferencefit” denotes the fit between the ATA and the port, whereby there isinitial resistance and then relief once the ATA snaps into place. Thetip of the ATA is barbed to facilitate insertion into the port.Preferably, when placed on the infant's head, the port will face thefront or tragus side of the infant's ear, which corresponds to the flatportion of the “D” shaped coupler.

[0043] The ATA, 70, is an assembly that houses a transducer forgenerating the aural stimuli. It also may house other devices such as amicrophone for monitoring acoustic energy within the environment. TheATA is on the end of a cable, which connects it to the hearingevaluation device. The ATA snaps into the port, and may be positioned ineither an up or a down position, along the side of the ear coupler, asillustrated in FIGS. 11 & 12. The ATA can be rotated between the up anddown positions during screening, as shown in FIGS. 11 and 12. The ATAalso may include a latch that snaps onto to the ribs of the annular sidewall, helping to ensure that the ear coupler is not tugged away from thesubject's head. The ATA hugs or mates with the side of the ear coupler,which improves crush resistance and prevents the ATA from acting as alever which could pull the ear coupler off the subject's head. Morespecifically, the ATA has an arm 72 that extends laterally away from theport 60 when the ATA 70 is placed into the port 60. See FIGS. 4, 7, 8,9, 10, and 11.

[0044] The tab, 80, is attached to or integral with the flange, and isused to help remove the ear coupler from the infant's head. Preferably,the tab, 80, is placed opposite to the port, 60, but could be placedanywhere on the periphery of the flange. The tab is also useful inremoving the ear coupler from the release paper.

[0045] Before use, the ear coupler is provided to the user attached torelease paper, to help ensure cleanliness and to preserve the stickingpower of the adhesive. Holes may placed in the portion of the releasepaper facing the bottom wall, to make it easier it to hold the couplerwhile inserting the ATA.

[0046] In operation, the ATA, 70, is inserted into the port, 60, andsnapped onto the ribs in either the up or down position, depending onthe operator's preference. The ear coupler, 10, is then removed from therelease paper and placed on the subject's head, so as to cover his orher ear. The adhesive on the flange, 50, holds the coupler in placeduring testing. As necessary, the ATA can be flipped from the up or downposition during testing to accommodate the particular position of thesubject. After testing, the ear coupler is removed, using the tab.

[0047] The present ear coupler is much less likely to become detachedduring testing than previous couplers, since its flexible, one-piecebody can better accommodate the irregular and curved shape of thesubject's head. It also is better able to move and stretch as necessaryin response to the subject's movements.

[0048] The present ear coupler is also less costly to manufacture, sinceit is preferably made of one-piece, and can be created using relativelyinexpensive processes such as injection molding and thermoforming.

[0049] The ear coupler can be used for hearing screening of infants,children, or adults, and can also be used as a sound-blocking “earmuff,” when a quiet acoustic environment is desired.

[0050] One skilled in the art will appreciate that the present inventioncan be practiced by other than the described embodiments, which arepresented for purposes of illustration and not limitation. Theparticular dimensions and materials recited herein are presented forpurposes of illustration and not limitation.

We claim: 1.) An ear coupler comprising; a one-piece body, said bodycomprising: an internal chamber, and a port in communication with saidchamber for receiving a hearing analysis transducer. 2.) The ear coupleraccording to claim 1, wherein substantially all portions of said bodyare transparent. 3.) The ear coupler according to claim 2, additionallycomprising a means for removably attaching the ear coupler to asubject's head. 4.) The ear coupler according to claim 3, wherein saidear coupler is made by injection molding. 5.) The ear coupler accordingto claim 3, wherein said ear coupler is made by thermoforming. 6.) Amethod of conducting hearing analysis, comprising: providing an earcoupler according claim 1, 2, 3, 4, or 5; attaching said ear coupler toa subject; and conducting hearing analysis. 7.) An ear coupler assemblycomprising a body; a port in said body, said port having a longitudinalaxis extending into and out of said port; an acoustic transducerassembly capable of being releasably attached to said port so that aportion of said assembly extending from said port is generallyperpendicular to said longitudinal axis. 8.) An ear coupler assemblycomprising: a body; a port in said body, said port having a longitudinalaxis extending into and out of said port; an acoustic transducerassembly, wherein said acoustic transducer assembly has an arm, andwherein said arm extends laterally away from said port when saidacoustic transducer assembly is fitted in said port. 9.) An ear coupler,comprising: a body; a flange disposed about said body; and a barrier onsaid flange for containing adhesive. 10.) The ear coupler according toclaim 8, additionally comprising a port in said body. 11.) The earcoupler according to claim 9, additionally comprising a tab on saidflange. 12.) The ear coupler according to claim 9, 10, or 11, whereinsubstantially all portions of said body are transparent.